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FDA 510(k) Application Details - K070878
Device Classification Name
Thermometer, Electronic, Clinical
More FDA Info for this Device
510(K) Number
K070878
Device Name
Thermometer, Electronic, Clinical
Applicant
RG MEDICAL DIAGNOSTICS
21130 BRIDGE STREET
SOUTHFIELD, MI 48034 US
Other 510(k) Applications for this Company
Contact
RONALD G LE TOURNEAU
Other 510(k) Applications for this Contact
Regulation Number
880.2910
More FDA Info for this Regulation Number
Classification Product Code
FLL
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
03/29/2007
Decision Date
06/05/2007
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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